Anamorelin - Helsinn Therapeutics/Ono Pharmaceutical

Drug Profile

Anamorelin - Helsinn Therapeutics/Ono Pharmaceutical

Alternative Names: Adlumiz; Anamorelin HCl; Anamorelin hydrochloride; ONO-7643; RC-1291; RC-1291 HCl; ST-1291

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Novo Nordisk
  • Developer Helsinn Therapeutics; Ono Pharmaceutical
  • Class Appetite stimulants; Piperidines; Small molecules
  • Mechanism of Action Ghrelin receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Anorexia; Cachexia
  • Phase II Fatigue

Most Recent Events

  • 20 Aug 2018 M. D. Anderson Cancer Center and National Cancer Institute plan a phase II/III trial for Anorexia in USA (PO), in December 2018 (NCT03637816)
  • 02 Feb 2018 Phase-III clinical trials in Anorexia in Japan (PO) (Ono Pharmaceutical pipeline, February 2018)
  • 15 Sep 2017 Committee for Medicinal Products for Human Use (CHMP) recommends the refusal of the marketing authorisation for anamorelin for Anorexia and Cachexia in European Union as the benefits of anamorelin do not outweigh the potential risks
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